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Clinical trial Recruiting at 7 sites Interventional Ages 18 and up

IRIS-CKD Program 2: Improving screening and management for chronic kidney disease in people with type 2 diabetes

Official title: Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 2) (IRIS-CKD)

Run by Duke University · NCT06906640 · Data updated 2026-11-12

This program will test whether a guided management program (plus education) helps doctors prescribe recommended CKD medicines for adults with type 2 diabetes and lab evidence of kidney disease.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment212 (estimated)
SponsorDuke University
Academic / other
Locations7 sites (Birmingham, Alabama and 6 other locations)
StatusRecruiting
StartedOctober 28, 2025
Main results expectedApril 1, 2027
Study endsApril 1, 2027
Registry record updatedOctober 1, 2026
Trial IDNCT06906640 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with type 2 diabetes who receive primary care within a participating health system, have laboratory evidence of CKD (e.g., UACR >300 mg/g, eGFR <45, or UACR ≥30 mg/g with eGFR <60), and are not already receiving 100% guideline-directed medical therapy are ideal candidates.

Probably not a fit

People with type 1 diabetes, very low eGFR (<20 ml/min/1.73 m2), prior kidney transplant, autosomal dominant polycystic kidney disease, active pregnancy, or those already fully treated with GDMT are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

IRIS-CKD Program 2 compares a guided management program to education alone to increase prescription of guideline-directed medical therapy (GDMT) for people with type 2 diabetes and chronic kidney disease. Eligible patients are identified through primary care at participating health systems, consented at site, given educational materials, and randomized to receive GDMT-guided management or education-only per site procedures. Prescribing will be measured over about six months using opportunity scores that account for variable indications for each medication. The primary outcome is whether the guided management approach increases appropriate prescriptions of ACEi/ARB, SGLT2 inhibitors, and finerenone as indicated.

Why it matters

Potential benefit: If successful, this approach could increase use of proven kidney-protective medicines and help slow CKD progression in people with type 2 diabetes.

How similar studies have gone: Individual drug trials and some implementation efforts have improved CKD outcomes and medication uptake, but multi-site programs specifically designed to increase GDMT prescribing for CKD in T2D are relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* (CKD Management)

  * Adults with type 2 diabetes (T2D)
  * Receiving primary care within the healthcare system, visit within 24 months (any PCP provider, including APP)
  * Evidence of CKD based on laboratory testing within the past 2 years (must be confirmed during screening if not checked within 3 months of enrollment):

    * UACR \>300 mg/g or
    * eGFR \<45 ml/min/1.73 m2 or
    * UACR ≥30 mg/g with eGFR \<60 ml/min/1.73 m2
  * Receiving \<100% GDMT at baseline. For patients with UACR \<30 mg/g, GDMT includes sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy. For all other eligible patients, GDMT includes ACEi/ARB, SGLT2i, and Finerenone, unless contraindications for any of these therapies exist (e.g., hyperkalemia, diabetic ketoacidosis, etc.).

Exclusion Criteria:

* (CKD Management)

  * Type 1 diabetes
  * Most recent eGFR \<20 ml/min/1.73 m2
  * Prior kidney transplant
  * Autosomal dominant polycystic kidney disease (ADPKD)
  * Active pregnancy or plans for conception within 1 year

Where it's running

  • University of Alabama
    Birmingham, Alabama, United States     Recruiting
  • Orlando Health
    St. Petersburg, Florida, United States     Recruiting
  • University of Michigan
    Ann Arbor, Michigan, United States     Recruiting
  • Essentia Institute of Rural Health
    Duluth, Minnesota, United States     Recruiting
  • Duke University
    Durham, North Carolina, United States     Recruiting
  • Houston Methodist
    Houston, Texas, United States     Recruiting
Show 1 more location
  • Baylor Scott & White
    Temple, Texas, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Chronic Kidney Disease(CKD) 24Type 2 DM 3Type 2 Diabetes Mellitus (T2DM) 68Duke University 2174
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.